As boxes of Pfizer vaccine began arriving in the country this week, hospital pharmacists made a startling discovery: Some of the glass vials said to contain five doses contained enough for a sixth – if not a seventh – person.
The news sparked a wave of enthusiastic discussion on Twitter and on pharmacy bulletin boards this week, as hospital workers contemplated the tantalizing possibility that the limited supply of vaccines desperately needed could be expanded to reach more people.
But it also sparked confusion and debate over whether to use the extra doses or throw them away. At Northwell Health in New York, for example, an executive estimated that the hospital network could have thrown out enough additional vaccines to account for 15 to 20 doses while awaiting advice from the state’s health department.
On Wednesday, pharmacists got a response. In a statement, the Food and Drug Administration said that, “given the public health emergency,” it was acceptable to use every full dose left in each vial. The agency said it was consulting with Pfizer to determine “the best way forward” and advised health officials not to bundle doses from multiple vials.
“We never want to waste – waste drugs, waste vaccines,” said Anna Legreid Dopp, senior director of clinical guidelines and quality improvement at the American Society of Health-System Pharmacists. “So it would be exciting if that was an opportunity.”
The vaccine, which was developed by Pfizer and the German company BioNTech, is extremely rare. Pfizer said it has made enough vaccine to deliver at least 25 million doses – enough for 12.5 million people because it requires two injections – in the United States before the end of the year, but federal officials have it. allocated carefully, distributing just 2.9 million doses as of this week after the FDA cleared its emergency use last Friday.
Because the vaccine is so rare, it is first given to frontline healthcare workers, residents and nursing home staff, and experts said a vaccine would not be available to all. Americans who want one before next year.
In a statement, Pfizer said the company was consulting with the FDA about the additional vaccine in some vials and could not “provide a recommendation on how to use the remaining amount of vaccine in each vial.” He advised staff performing immunizations to consult with local institutions.
Erin Fox, senior director of pharmacy information and support services at the University of Utah, said she received a call from pharmacists on her staff on Tuesday, shortly after she began to dilute the vaccine with saline solution and put it in syringes.
A little “overfill” in vials with multiple doses is normal, she said, but it was different. “They initially thought they had done it incorrectly because there was so much left in the vial after taking out the five doses,” Ms. Fox said. “They sent us a picture and said, can we use the supplement?”
Ms Fox said her staff contacted Pfizer as well as the Utah Department of Health, who told them not to use the extra doses because it was not according to company instructions. She said the doses had been discarded, but staff would now start preparing additional doses.
Northwell Health quality manager Dr Mark Jarrett said on Wednesday that clinicians administering the Pfizer vaccine to healthcare workers this week noticed that some vials contained enough for a sixth dose. The health system has asked the New York State Department of Health for advice on whether to use it.
Dr Jarrett said that “some people used the sixth dose because they didn’t recognize the question about it”. But Northwell is only dispensing five doses from each vial and throwing away the extra medicine – roughly 15 to 20 doses on Tuesday.
He said he had yet to see the FDA advice “We have to see it documented somewhere, it would make us feel better,” he said.
New York state health officials contacted the FDA for advice on Wednesday morning after learning of the problem that morning, according to a spokesperson for the Department of Health. On a call Wednesday with nearly 200 healthcare providers, the state’s health commissioner, Dr Howard A. Zucker, discussed the matter and said additional doses could be used.
Healthcare consultant Dr Michael J. Consuelos said that during the H1N1 flu pandemic in 2009, hospital pharmacists made a similar discovery at the Lehigh Valley Health Network in Pennsylvania, where he later worked at the overseeing the pandemic response. This vaccine was also rare and the authorities decided to use the extra doses.
“What we want to do is deliver as many doses to people in the safest and most efficient way possible,” said Dr Consuelos, who said he volunteered for the vaccine trial. Pfizer. If hospital professionals can do this safely, “then we have to seize these opportunities”.
News that hospitals may be able to immunize more people than expected is also creating new complications. Federal officials carefully managed the vaccine supply, keeping enough doses in reserve so that everyone who received the first dose received a booster shot three weeks later.
Ms Dopp said hospitals rushing for additional doses will need to make sure the person gets the second vaccine that is waiting for them. “This is where we really need agile tracking systems and real-time information systems to be able to make those decisions quickly,” she said.
But Ms Dopp admitted that it was also a good problem to have. “These are some of the lessons that we cannot learn until the vaccine is available,” she said.
Roni Caryn Rabin contributed reporting.